Area under the plasma concentration vs time curve over the dosing interval, at steady state (AUCtau) of metformin [ Time Frame: 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Days 5 and 10 ] [ Designated as safety issue: No ]

Area under the plasma concentration versus time curve over the dosing interval, at steady state (AUCtau) of ranolazine and metabolites [ Time Frame: 0, 0.5, 1,1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 10 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

Official Title ICMJE

A Phase 1, Open-label, Single Cohort, Two-Period Fixed Sequence Study to Assess the Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg Twice Daily in Subjects With Type 2 Diabetes Mellitus

Brief Summary

The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus (T2DM).

Detailed Description

The primary objective of this study is as follows:

• To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady state pharmacokinetics (PK) of metformin in subjects with T2DM.

The secondary objectives of this study are as follows:

To examine the safety and tolerability of metformin when co administered with ranolazine 500 mg bid at steady-state in subjects with T2DM.

To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM receiving metformin.

Study Type ICMJE

Interventional

Study Phase

Phase 1

Study Design ICMJE

Endpoint Classification: Pharmacokinetics StudyIntervention Model: Single Group AssignmentMasking: Open Label

Condition ICMJE

Type 2 Diabetes Mellitus

Intervention ICMJE

Drug: Metformin

Metformin 1000 mg bid on Days 1-10

Other Name: Glucophage

Drug: Ranolazine

Ranolazine 500 mg bid on Days 6-10

Other Name: Ranexa

Study Arm (s)

Experimental: Metformin, Ranolazine

Single cohort, 2-period study:

Period 1, metformin 1000 mg bid on Days 1-5

Period 2, metformin 1000 mg bid + ranolazine 500 mg bid on Days 6-10

Interventions:

Drug: Metformin

Drug: Ranolazine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug